Efficacy and mechanisms of cannabis oil for alleviating side effects of breast cancer chemotherapy (CBC2): protocol for randomized controlled trial.



Thu, May Soe, Pongpirul, Krit ORCID: 0000-0003-3818-9761, Vongsaisuwon, Mawin, Vinayanuwattikun, Chanida, Banchuen, Kamonwan, Ondee, Thunnicha, Payungporn, Sunchai, Phutrakool, Phanupong, Nootim, Preecha, Chariyavilaskul, Pajaree
et al (show 3 more authors) (2024) Efficacy and mechanisms of cannabis oil for alleviating side effects of breast cancer chemotherapy (CBC2): protocol for randomized controlled trial. BMC complementary medicine and therapies, 24 (1). p. 130.

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Abstract

<h4>Background</h4>In a pilot study using both cannabidiol (CBD) and tetrahydrocannabinol (THC) as single agents in advanced cancer patients undergoing palliative care in Thailand, the doses were generally well tolerated, and the outcome measure of total symptom distress scores showed overall symptom benefit. The current study aims to determine the intensity of the symptoms experienced by breast cancer patients, to explore the microbiome profile, cytokines, and bacterial metabolites before and after the treatment with cannabis oil or no cannabis oil, and to study the pharmacokinetics parameters and pharmacogenetics profile of the doses.<h4>Methods</h4>A randomized, double-blinded, placebo-controlled trial will be conducted on the breast cancer cases who were diagnosed with breast cancer and currently receiving chemotherapy at King Chulalongkorn Memorial Hospital (KCMH), Bangkok, Thailand. Block randomization will be used to allocate the patients into three groups: Ganja Oil (THC 2 mg/ml; THC 0.08 mg/drop, and CBD 0.02 mg/drop), Metta Osot (THC 81 mg/ml; THC 3 mg/drop), and placebo oil. The Edmonton Symptom Assessment System (ESAS), Food Frequency Questionnaires (FFQ), microbiome profile, cytokines, and bacterial metabolites will be assessed before and after the interventions, along with pharmacokinetic and pharmacogenetic profile of the treatment during the intervention.<h4>Trial registration</h4>TCTR20220809001.

Item Type: Article
Uncontrolled Keywords: Humans, Cannabis, Breast Neoplasms, Cannabidiol, Cytokines, Pilot Projects, Thailand, Female, Randomized Controlled Trials as Topic
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Infection, Veterinary and Ecological Sciences
Depositing User: Symplectic Admin
Date Deposited: 09 Apr 2024 08:55
Last Modified: 09 Apr 2024 13:21
DOI: 10.1186/s12906-024-04426-0
Open Access URL: https://doi.org/10.1186/s12906-024-04426-0
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3180169